Phase 1Completed
A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers
A Randomised, Double-blind, Placebo-controlled, SAD/MAD First-in-human, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RXC007 Including Evaluation of Drug-Drug Interaction and Food Effect in Male Participants
- Sponsor
- Redx Pharma Ltd (Industry)
- Enrolment
- 90 enrolled
- Conditions
- Fibrosis; Inflammation; Idiopathic Pulmonary Fibrosis; Non-alcoholic Steatohepatitis; Liver Diseases; Kidney Diseases
- Interventions
- RXC007; RXC007 Matching Placebo
- Ages
- adults
- Registry
- NCT04931147
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007.
Primary outcomes
- Treatment Emergent Adverse Events
- Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit.
- Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to post-study follow up visit.
- Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, PR interval, QRS width, QT interval and QTcF interval) from first dose on Day 1 to post-study follow up visit.
History
Last registry update
Primary completion
Registered
Started